FDA Registration
Active
🇨🇦 Canada
Philips dS Breast 16ch 3T
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K072873
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Coil, Magnetic Resonance, Specialty | MOS | Class 2 | Radiology | No | 2009-05-19 |
Proprietary Names
Philips dS Breast 16ch 3T
MammoTrak Diagnostic Breast Coil 1.5T
Philips dS Breast 16ch 1.5T
MammoTrak Interventional Breast Coil 3T
Siemens 16 CH Breast 3T (LBS)
Mammotrak Diagnostic Coil 3T
Mammotrak Diagnostic Coil 1.5T
dS Breast 16ch 3T
Philips MammoTrak Interventional Breast Coil, 3T, 7CH
Philips MammoTrak Interventional Breast Coil, 3T, 16CH
dS Breast 16ch 1.5T
Mammotrak Interventional Coil 3T
Establishment Types
Export Device to the United States But Perform No Other Operation on Device